Kornimate/medical-research-clean huggingface dataset:
study of dcc-2812 in participants with advanced genitourinary cancers

Conditions: Renal Cell Carcinoma; Urothelial Carcinoma; Castration-resistant Prostate Cancer

Summary: this is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (gcn2) activator dcc-2812 as monotherapy in advanced/metastatic renal cell carcinoma (rcc), urothelial carcinoma, and castration-resistant prostate cancer.


Eligibility criteria:
key inclusion criteria: * have confirmed advanced or metastatic renal cell carcinoma, urothelial cancer, or castration-resistant prostate cancer * able to take oral medication * if a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements * adequate organ function and electrolytes key exclusion criteria: * received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of dcc-2812 * impaired cardiac function * major surgery within 28 days of the first dose of study drug

Keywords: advanced malignancies
the cloudupdrs smartphone software in parkinson's study.

Conditions: Parkinson's Disease

Summary: this study compares the validity and usability of smartphone software for home monitoring of symptoms and signs in parkinson's disease as compared to the current clinical gold standard - the unified parkinsons disease rating scale.

parkinson's disease (pd) is a neurodegenerative condition, which when treated can result in fluctuating motor activity - sometimes too much movement, sometimes too little. a series of tests, run on a smartphone, will be used to evaluate the motor signs of parkinson's and related to a clinical evaluation based on the unified parkinson's disease rating scale. 60 participants will be recruited.

Eligibility criteria:
inclusion criteria: 1. diagnosed with probable idiopathic parkinson's disease according to brain bank criteria (gibb and lees, 1988). 2. over 18 years old. 3. achieve \>20/30 on the montreal cognitive assessment (moca). 4. they must have been on the current parkinson's disease medication schedule for at least a week and have no plans to change this during the period of testing. 5. they must have the capacity to consent to take part in the study. 6. they must be able to understand english to the level of being able to operate the phone software, follow its instructions and be able to answer the study questions. exclusion criteria: 1. acute medical illness. 2. any other co-morbidity that in the opinion of the investigator may preclude their participation in the study. 3. unable to consent to the study.
comparison between ha330 hemoperfusion filter hemodialysis and conventional high-flux hemodialysis filter

Conditions: Renal Dysfunction; Sepsis; Hemodialysis

Summary: the purpose of this study is to compare the effectiveness between conventional hemodialysis and hemodialysis using hemoperfusion adsorbents in renal dysfunction caused by sepsis

this study is an open randomized clinical trial. data were taken prospectively until the number of samples was fulfilled for analysis. due to the intervention provided, this study was not blinded. subjects were divided into 2 groups (group undergoing conventional hemodialysis and group undergoing ha330 hemoperfusion). both groups underwent therapy for 4 hours, 3 times a week, with two days apart between dialysis. inflammatory mediator levels were assessed 4 times, before and after each intervention. all subjects were given standard therapy as indicated such as antibiotics, oxygen supplementation, administration of vasopressors, nutrition, and other therapies as indicated.

Eligibility criteria:
inclusion criteria: * patients age 18 - 65 years old * patients diagnosed with sepsis with acute kidney injury whose indicated for hemodialysis. including fluid overload, life-threatening metabolic acidosis, hypercalcemia, pulmonary edema, and uremic exclusion criteria: * patients with hemodynamic instability who need norepinephrine more than 0.5 microgram/kg/minute * patients denied to be included in the study
plant-based meat vs animal "red" meat trial

Conditions: Inflammatory Response

Summary: to assess the changes in the circulating levels of tmao after 1-week of beef or plant-based burger diet.

single-center, randomized, single-blinded cross-over trial including healthy adult participants (n=40, omnivores, aged between 25 and 65 years, and with a body mass index (bmi) between 20 and 40 kg/m2 (see participation criteria below). participants will be randomized to either red meat (cow burger) or plant "meat" (plant-based burger). the primary outcome will be the within-group change in the tmao levels.

Eligibility criteria:
inclusion criteria: * ≥ 25 years and ≤65 of age * bmi ≥20 kg/m2 and ≤40 kg/m2 * no known kidney disease * no antibiotics in the previous 30 days exclusion criteria: * any person who does not meet the above criteria and/or who refuses to participate * food allergies (specific ingredients contained in the patties)

Keywords: tmao red meat plant-base nutrition cardiovascular diseases
clinical study to investigate visual performance of iol: finevision hp

Conditions: Cataract; Lens Opacity

Summary: this is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced tga (therapeutics goods authority, australia) approved trifocal intraocular lens finevision evo (physiol, liège, belgium). the primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with iol implantation. subjects would have the option for unscheduled visits if required medically. primary endpoint data will be collected at the final visit. data analyses will be done in the end to support the study publication plan.

Eligibility criteria:
inclusion criteria: * cataracteous eyes with no comorbidity * spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * unrealistic expectation * irregular astigmatism * regular corneal astigmatism \>0.75 d on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry) * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * complicated surgery

Keywords: intraocular lens trifocal cataract physiol
a study of hs-20093 vs active surveillance in limited-stage small cell lung cancer

Conditions: Limited-stage Small-cell Lung Cancer

Summary: this study will evaluate the efficacy, safety and tolerability of hs-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.

this is a randomized, controlled, open-label, multi-center, phase iii clinical study to evaluate the efficacy and safety of hs-20093 versus active surveillance as consolidation therapy in participants with limited-stage small cell lung cancer (ls-sclc) who have not progressed after receiving chemoradiotherapy (crt). this study consists of an experimental arm and a control arm. the experimental arm will be administered hs-20093, and the control arm will only receive active surveillance. efficacy and safety were assessed in both arms by follow-up analyses.

Eligibility criteria:
inclusion criteria: 1. have signed informed consent form. 2. males or females ≥18 years old. 3. patients with limited-stage sclc who are deemed unsuitable for surgery or decline surgery. 4. ecog performance status of 0-1. 5. patients who have received crt and have not progressed. 6. minimum life expectancy \> 12 weeks. 7. males or females should be using adequate contraceptive measures throughout the study. 8. females must not be pregnant at screening or have evidence of non-childbearing potential. exclusion criteria: 1. patients with mixed sclc or nsclc or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma. 2. patients with extensive-stage sclc. 3. disease progression during crt or before randomization. 4. received or are receiving the following treatments: 1. for ls-sclc, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide 2. received any other anti-cancer treatment. 3. previous or current treatment with b7-h3 target therapy. 4. traditional chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug. 5. major surgery within 4 weeks prior to the first dose of study drug. 5. interstitial lung disease (ild)/non-infectious pneumonitis. 6. history of other primary malignancies. 7. inadequate bone marrow reserve or organ functions. 8. severe, uncontrolled or active cardiovascular disorders. 9. severe or uncontrolled diabetes. 10. serious or poorly controlled hypertension. 11. severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization. 12. severe arteriovenous thrombosis occurred within 3 months prior to randomization. 13. serious infection within 4 weeks prior to randomization. 14. presence of grade ≥ 2 toxicities due to prior anti-tumor therapy. 15. having serious neurological or mental disorders. 16. history of hypersensitivity to any component of hs-200093 or its similar drugs. 17. participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
long-term, open-label study of sar447537 (inbrx-101) in adults with alpha-1 antitrypsin deficiency emphysema

Conditions: Alpha 1-Antitrypsin Deficiency; Emphysema

Summary: phase 2 open label extension study to evaluate sar447537 (inbrx-101) in adults with aatd emphysema

this is a phase 2, single arm, open label extension study, evaluating the long-term safety and clinical efficacy of sar447537 (inbrx-101) in adults with alpha-1 antitrypsin deficiency (aatd) emphysema.

Eligibility criteria:
inclusion criteria: 1. males or females 18-80 years of age, inclusive, at the time of screening 2. diagnosis of aatd 3. evidence of emphysema secondary to aatd 4. fev1 of ≥ 30% predicted at screening and post-bronchodilator fev1/fvc\<0.7 5. current non-smoking status exclusion criteria: 1. receipt of a1pi augmentation therapy within 5 weeks prior to the first dose of study drug 2. known or suspected allergy to components of sar447537, a1pi or human igg 3. known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes 4. received iv immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days 5. on waiting list for lung or liver transplant 6. acute respiratory tract infection or copd exacerbation within 4 weeks prior to or during screening 7. evidence of decompensated cirrhosis 8. active cancers or has a history of malignancy within 5 years prior to screening 9. history of unstable cor pulmonale 10. clinically significant congestive heart failure the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: aatd alpha 1-antitrypsin deficiency emphysema inbrx-101 aat sar447537
vopratelimab (jtx-2011) alone and in combination with anti-programmed cell death protein 1 (pd-1) or anti-cytotoxic t-lymphocyte antigen 4 (ctla-4) in subjects with advanced and/or refractory solid tumors

Conditions: Cancer

Summary: jtx-2011-r01 is an open label, multicenter, rollover study that is designed to provide continued access to vopratelimab for eligible subjects with advanced solid tumor malignancies who have previously participated in a vopratelimab study (the parent study).

vopratelimab is an agonist monoclonal antibody that specifically binds to the inducible co-stimulator of t cells (icos) to generate an anti-tumor immune response. this is an open label, roll over study to evaluate the long-term safety of continued treatment with vopratelimab monotherapy or combination treatment.

Eligibility criteria:
inclusion criteria: * subject is currently receiving and tolerating vopratelimab (jtx-2011) therapy and receiving clinical benefit from study treatment in the opinion of the investigator and/or sponsor. * subject has demonstrated compliance with the parent study requirements, as assessed by the investigator and/or sponsor, and is able and willing to comply with the necessary visits and assessments as part of the rollover study. * written informed consent must be obtained prior to enrolling in the rollover study and receiving study treatment. if consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. * women of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment exclusion criteria: * subject was permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason. * subject is receiving concurrent anti-cancer treatment (excluding combination drugs such as nivolumab or ipilimumab as a component of the combination dosing regimen used in parent study). * women who are pregnant or breastfeeding. * subject has any medical or social condition that, in the opinion of the investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical study data interpretation.

Keywords: jtx-2011 vopratelimab ipilimumab nivolumab icos anti-ctla-4 pd-1 pd-l1 immunotherapy immuno-oncology cancer
clinical study to investigate visual performance of a hydrophobic monofocal iol after bilateral implantation

Conditions: Cataract; Lens Opacities

Summary: prospective, non-randomised, open, controlled, single-center post-market clinical follow study about micropure 1.2.3 iol.

this clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have bilateral implantation of monofocal intraocular lenses micropure 1.2.3. (physiol, liège, belgium) the study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with micropure 1.2.3. the device under investigation (micropure 1.2.3.) is a monofocal glistening-free hydrophobic acrylic intraocular lens (iol) manufactured by the sponsor of this study physiol sa/nv. the iol will be implanted as part of the routine cataract surgery on patients suffering from cataract development. in total 50 patients will be recruited for this clinical study and receive a bilateral implantation of micropure 1.2.3. intraocular lens. subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 years.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * irregular astigmatism * age of patient \< 45 years * regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120° * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * complicated surgery * patients who do not give informed consent

Keywords: intraocular lens monofocal hydrophobic
an efficacy and safety study with integrated pharmacokinetics (pk) and pharmacodynamic (pd) assessment to compare the proposed ocrelizumab biosimilar cyb704 and ocrevus in participants with relapsing multiple sclerosis (rms)

Conditions: Relapsing Multiple Sclerosis

Summary: the goal of this clinical trial is to learn if drug cyb704, a proposed biosimilar to ocrevus, works to treat multiple sclerosis in the same way as the reference product ocrevus(r). the main questions it aims to answer are: * is cyb704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (pk) similarity)? * does have cyb704 the same treatment effect and side effects as the reference product? researchers will compare cyb704 to a ocrevus (ocrevus-us and ocrevus-eu) (participants will: * take drug cyb704 or ocrevus (ocrevus-us and ocrevus-eu) * visit the clinic for a t least 15 treatment visits, checkups and tests * will undergo regular magnetic resonance imaging (mri) examinations


Eligibility criteria:
inclusion criteria: * diagnosis of rms (relapsing remitting multiple sclerosis (ms) and active secondary progressive ms) * evidence of recent disease activity as defined in study protocol * expanded disability status scale score of 0 to 5.5 (inclusive) at screening * neurological stability (no new signs or symptoms referable to central nervous system (cns) within 30 days before both screening and first study treatment exclusion criteria: * diagnosis of primary progressive ms * disease duration of more than 10 years in participants with an expanded disability status scale (edss) ≤2.0 at screening * inability to complete an mri or contraindication to gadolinium administration * history of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic) * pregnant participants * current or history of medical conditions as outlined in the study protocol * prohibited medications (current and history) as outlined in the study protocol * abnormal laboratory blood values as outlined in the study protocol
stivarga real life evidence in hungary

Conditions: Colorectal Neoplasms

Summary: the study aims to evaluate use of regorafenib in clinical practice in hungary. the study should provide information about clinical characteristics of hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in hungarian patients with metastatic colorectal cancer. this much needed data is required by the national health insurance fund in order to accept regorafenib into the regular reimbursement system. this study is proposed to be based on patient data from the hungarian national health insurance fund's database. data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. further, treatment costs will be estimated.


Eligibility criteria:
inclusion criteria: * using the national health insurance database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days). exclusion criteria: * not applicable

Keywords: metastatic colorectal cancer
indomethacin versus nifedipine for preterm labor tocolysis

Conditions: Obstetric Labor, Premature

Summary: indomethacin and nifedipine are commonly used medications for treatment of pre term labor. this study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective. patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. both the patient and primary medical provider will be blinded to the identity of the study drug. an abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. the patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. tocolysis beyond 48 hours will not be used.

patients presenting between 24-34 weeks gestation diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. both the patient and primary medical provider will be blinded to the identity of the study drug. an abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. the patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. tocolysis beyond 48 hours will not be used. antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.

Eligibility criteria:
inclusion criteria: * singleton and twin gestations * intact amniotic membranes * no contra-indications to tocolysis * 24-34 weeks gestation by last menstrual period and/or ultrasound * documented cervical change, and regular painful uterine contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement exclusion criteria: * ruptured amniotic membranes * signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 f/38.0 c, fetal tachycardia, uterine tenderness) * non-reassuring fetal heart rate tracings * contra-indications to indomethacin or nifedipine * contra-indications to tocolysis